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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02645097
Other study ID # IRB - 39025
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date December 2016

Study information

Verified date June 2019
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.


Description:

This is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary objectives are to compare the pain relief and quality of life of participants in these two groups.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age 18-65

- Upcoming elective foot or ankle surgery

Exclusion Criteria:

- Preoperative weakness in knee extension

- Documented neuropathy

- Previous knee surgery

- Inability to provide informed consent

Study Design


Intervention

Procedure:
Saphenous Nerve Block
A nerve block will be performed by the anesthesiologist. The location of the nerve block will be per randomization envelope (proximal vs. distal) and performed just prior to foot or ankle surgical procedures that require a saphenous nerve block

Locations

Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Paul J. Juliano, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary knee extensor strength measured in kilograms Strength of the knee extensors in both treatment arms (distal vs. proximal block) will be tested preoperatively and again 30 minutes after the nerve block by using a hand-held dynamometer measured in kilograms change from baseline preoperatively to 30 minutes after nerve block placement
Secondary pain level Pain relief will be measured by review of the medical record for type and amount of pain medications used change from baseline preoperatively to two weeks post-operatively
Secondary quality of life assessment PROMIS Global Health Survey will be completed by patients in both treatment arms pre-operatively and again two weeks post-operatively change from baseline preoperatively to two weeks post-operatively
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